US8066763B2 - Drug-releasing stent with ceramic-containing layer - Google Patents
Drug-releasing stent with ceramic-containing layer Download PDFInfo
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- US8066763B2 US8066763B2 US12/777,705 US77770510A US8066763B2 US 8066763 B2 US8066763 B2 US 8066763B2 US 77770510 A US77770510 A US 77770510A US 8066763 B2 US8066763 B2 US 8066763B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
- A61F2002/91541—Adjacent bands are arranged out of phase
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
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Definitions
- the present invention relates generally to stents which are implantable or deployable in a vascular or endoluminal location within the body of a patient to maintain the lumen open at the implant site, and more particularly to improvements in stent coatings.
- Stents are expandable prostheses employed to maintain narrow vascular and endoluminal ducts or tracts of the human body open and unoccluded, such as a portion of the lumen of a coronary artery after dilatation of the artery by balloon angioplasty, for example.
- the original blockage typically arises from a buildup of fatty deposits or plaque on the inner lining of the vessel.
- the balloon angioplasty procedure is used to compress the deposits against the inner lining of the vessel, or virtually entire removal may be achieved using other types of angioplasty such as laser or rotational cutting.
- a different mechanism may cause a new blockage after the angioplasty procedure is performed.
- the blood vessel wall is subjected to trauma by the balloon, laser or rotating knife, as the case may be, which results in intimal hyperplasia, i.e., a rapid proliferation of smooth muscle cells in the affected region of the wall, to cause restenosis and re-occlusion of the vessel lumen in a significant percentage of angioplasty patients within a period of from three to six months following the initial procedure.
- intimal hyperplasia i.e., a rapid proliferation of smooth muscle cells in the affected region of the wall
- a stent at the site in the vessel where the angioplasty was performed.
- the stent is deployed by radial expansion under pressure exerted, for example, by active inflation of a balloon of a balloon catheter on which the stent is mounted, or in some instances by passive spring characteristics of a pre-formed elastic stent, to engage the inner lining or inwardly facing surface of the vessel wall with sufficient resilience to allow some contraction but also with sufficient stiffness to resist to a great degree the natural recoil of the vessel wall that follows its expansion.
- the stent itself offers a surface that can promote thrombus formation as blood flows through the vessel. This can result in an acute blockage, which, in a coronary artery, is sufficient to produce an infarction.
- the thrombosis and clotting can be reduced or even eliminated by localized application of appropriate drugs in a biodegradable formulation, which act for only a period of time sufficient to stave off the thrombus reaction to the presence of the stent in the bloodstream.
- a similar situation is encountered at the outward facing surface of the stent that contacts and engages the inner lining of the vessel, duct or tract, where tissue irritation can exacerbate fibrosis of the vessel wall and restenosis in the region of the irritation.
- tissue irritation can exacerbate fibrosis of the vessel wall and restenosis in the region of the irritation.
- An additional need encountered for stent usage in the human body include a capability to clearly visualize the stent as it is being implanted at the preselected site in the body, as by advancement on a stent delivery system through a portion of the patient's vascular system and into a coronary artery, and after the stent is implanted, for purposes of its examination from time to time at the implant site.
- the device should be flexible, and yet possess sufficient mechanical strength to resist vessel recoil. It should demonstrate a high rate of successful interventional placement, be highly visible on x-ray fluoroscopy, be very thin to minimize obstruction by its mere presence in the lumen intended to be dilated and held open, and not be an agent which promotes a re-narrowing or re-occlusion of the vessel or duct lumen in which it is implanted.
- Stent design can play a major role in influencing the aforementioned features, but also significant is the material(s) of which the stent is composed, with respect to visibility, flexibility, and recoil-resistant characteristics of the stent, as well as its surface characteristics that affect capability of the stent to prevent or inhibit thrombus formation and restenosis in a blood vessel in which the stent is implanted. Current stents have not proved to be capable of fulfilling all of these requirements.
- a stent is adapted for deployment in a blood vessel of a human body to maintain the lumen of the vessel open for adequate flow of blood therethrough in the region in which the stent is deployed.
- the stent has the basic form of an open-ended tubular element with openings through a side thereof, which is adapted to be expanded from a first outside diameter, which is sufficiently small to allow the stent and its delivery system to traverse the vascular system of the human body to reach a site in the blood vessel at which the stent is to be deployed, to a second outside diameter sufficiently large to engage the inner lining of the vessel for retention at the site.
- the tubular element or sidewall of the stent includes a first solid layer or thickness of a biocompatible metal, and a second porous layer or thickness which is composed of spherically-shaped metal particles bonded together to leave spaces between the particles.
- the metal particles are composed at least in part of a noble metal, and specifically, of a platinum-iridium alloy.
- the spaces between the particles advantageously provide a repository for drugs to assist in maintaining the lumen of the vessel open.
- the second thickness overlies the first thickness in tightly adherent relation thereto, and has a radiopacity which substantially exceeds that of the first thickness, to provide a highly visible view of the stent by x-ray fluoroscopy during its advancement and deployment in the blood vessel, and thereafter whenever the stent is to be examined in place.
- the stent includes at least one drug selected from a group consisting of anti-thrombotic, anti-platelet, anti-inflammatory and anti-proliferative drugs, residing in the repository.
- a biodegradable carrier may be used to retain the drugs for timed release thereof from the repository when the stent is deployed at the selected implant site in the blood vessel.
- the mere spacing of the metal particles may advantageously provide a timed release of the drugs from the repository.
- the particles which are sized in a range of diameters, are located with the larger diameter sizes adjacent and bonded to the surface of the first thickness and with those and progressively smaller diameter sizes bonded together up to the outermost region of the second thickness.
- the anti-platelet and/or anti-thrombotic drugs are preferably infused into the porous layer repository, i.e., into the spaces or interstices between the particles, existing at the inward facing surface (and if desired, at directly adjacent edges of the openings) of the stent to inhibit clogging of the lumen as a result of interaction between the stent itself and the blood flow therethrough.
- the anti-inflammatory and/or anti-proliferative drugs are preferably infused into the repository existing at the outward facing surface (and if desired, at directly adjacent edges of the openings) of the stent to inhibit restenosis as a result of fibrosis or proliferation of tissue from trauma to the inner lining of the vessel arising from contact with the stent.
- a third layer or thickness of a ceramic-like material is applied as a coating overlying exposed surfaces of the metal particles in tightly adherent relation to the second thickness at those surfaces, without filling or blocking the spaces between the particles, so that the repository for drugs originally formed in the second thickness remains available. Consequently, the desired drugs may be infused into the spaces between particles, in preferential locations as noted above, for retention and dispensing in the same manner as if the third thickness had not been applied. Additionally, the ceramic-like material is resistant to tissue irritation to further avoid such traumatic response during contact of the stent with the inner lining of the vessel at the site.
- a porous layer of substantially spherical metal particles is applied atop surfaces of a base metal of the stent, the metal particles at the base metal surfaces being bonded thereto and the metal particles throughout the porous layer being bonded together, with voids therebetween forming a reservoir for retention and dispensing of drugs from the stent when deployed in its vascular or endoluminal location.
- the metal particles exhibit a radiopacity that substantially exceeds the radiopacity of the base metal for high visibility viewing of the stent by fluoroscopy when advanced and deployed in the body.
- the exposed surfaces of the metal particles are coated with ceramic-like material consisting of iridium oxide or titanium nitrate while leaving the voids between the particles unblocked and substantially intact so that the reservoir remains available for infusing drugs therein.
- the base metal may, for example, be 316L stainless steel, chromium, nickel, titanium, or iridium, or nitinol which is a shape memory nickel-titanium alloy, nominally of 70 micrometers or microns ( ⁇ m) thickness.
- the metal particles of platinum-iridium alloy preferably have diameters ranging from about 50 to 500 nanometers, and the porous layer is applied atop the base metal to a thickness in a range from approximately 4 to 8 microns.
- the iridium oxide or titanium nitrate is coated on surfaces of the metal particles to a thickness in a range from approximately 50 to 500 nanometers.
- the desired drugs or other selected agents are infused into the reservoir provided by the voids or interstices between particles of the porous layer.
- Timed release of the drugs may be achieved by incorporating them in a biodegradable carrier.
- Gene transfer may alternatively be used to inhibit proliferation of smooth muscle cells, to prevent restenosis that could block the lumen of the vessel in which the stent is deployed.
- a viral vector transfers at least part of the genetic information of interest to the target cell.
- a gene transfer agent constituting the viral vector or virus is incorporated in a biodegradable carrier, or microspheres or liposomes as the viral vector are contained in solution, and the combination is infused into the reservoir of the multi-layer stent from which it is released in a substantially programmed manner to effect the gene transfer.
- a highly important aim of the invention resides in providing a basic structure of a stent which includes three fundamental layers, a first underlying layer constituting a base metal that functions to provide mechanical strength and flexibility, a second intermediate layer that functions to provide high fluoroscopic visibility—preferably a noble metal layer, and most preferably a principally platinum layer in which platinum is in an alloy with a small percentage (about 2%) of iridium—, and a top layer of particularly beneficial biocompatible material—preferably iridium oxide or titanium nitrate.
- the preferred embodiment utilizes a porous intermediate layer, and a remaining porous structure even after formation of the final biocompatible layer, in its most fundamental character the invention contemplates the use of a completely solid intermediate layer to provide the high visibility property and a highly suitable surface for strong bonding of the final coating. The latter itself offers a surface for attachment of the drug/agent-containing carrier.
- FIG. 1 is a partial perspective view of a basic form of vascular or endoluminal stent, incorporating a multi-layer structure according to the invention
- FIG. 2 is an exaggerated fragmentary cross-sectional detailed view of a portion of the multi-layer structure of the stent of FIG. 1 , through the line 2 - 2 thereof;
- FIG. 3 is a flow chart diagram illustrating the steps of a basic process for fabricating a multi-layer stent of the type illustrated in FIGS. 1 and 2 .
- a stent 10 may be of generally conventional configuration, with cylindrical structure having open ends, and of any known type such as the Palmaz-Schatz zig-zag tube type shown, or a mesh type, for example.
- the material of which the metal member 12 of the stent is composed i.e., the wire or the solid tube, may be of any conventional and suitable type, such as medical grade 316L stainless steel, chromium, nickel, titanium, iridium or nitinol, for example, which is biologically compatible (biocompatible) with the fluids and tissue of the human body.
- the sidewall 15 of member 12 is provided with a multiplicity of openings 16 that extend entirely through the wall.
- the openings are formed as a natural part of the formation of the mesh itself. If the stent is a helical spring-type of structure, the openings are simply the continuous winding space between the coils.
- openings may be cut in any conventional manner, such as by use of a cutting laser beam operating according to a computer-generated pattern. In the latter instance, care must be exercised to prevent the far side (relative to the position of the laser) of the tube from being cut at the same time that the near side cutting pattern is being produced.
- the openings 16 are sized in a conventional manner to assure that body fluids (including blood, in the case of a vascular stent) can contact much of the tissue of the inner lining of the wall of a vessel, duct or tract of the human body in which the stent is to be implanted.
- body fluids including blood, in the case of a vascular stent
- the production diameter (outer diameter) of the stent 10 may be in a range from about 1.5 millimeters (mm) to 2.0 mm.
- the production diameter (or subsequent compressed diameter) constitutes a first diameter which is sufficiently small to allow the stent to be inserted into the vessel, duct or tract of the body in which it is being used, and to be advanced to the site at which it is to be deployed.
- the stent is deployed by inflation of the balloon on which it is mounted to radially expand the diameter to a second diameter which is at least slightly larger than the diameter of the lumen of the vessel, duct or tract at that point.
- the stent 10 is illustrated as being partially expanded on its balloon catheter, for the sake of clarity. It is common practice to pre-mount a stent on a balloon 20 of a balloon catheter 23 (partially shown in the Figure) of the stent delivery system, and to supply the combination in a sterile package for convenience of ready use by the implanting physician. Alternatively, the stent could be mounted on the balloon by the physician at the time the procedure is to be performed. If the stent is to be deployed by passive spring characteristics as in the case of a pre-formed elastic stent, the delivery system need not include a balloon.
- the mounted stent is inserted into the patient's vascular system (not shown) at an appropriate location, and is then advanced on the balloon catheter to the selected site.
- the path of the stent to the site of deployment as well as identification of the target site in the coronary artery are viewed and determined by fluoroscopy.
- the balloon 20 is inflated by introducing a fluid through an inflation lumen of the catheter to radially expand the stent diameter to an extent that the stent will engage and exert at least slight pressure on the inner lining of the vessel wall.
- the balloon is deflated and the catheter 23 is withdrawn from the patient's vascular system and body.
- the stent 10 should possess sufficient rigidity in the fully deployed expanded state to prevent it from collapsing under the radially directed inward pressure exerted by the artery wall from natural recoil thereof as the balloon is deflated.
- the coronary artery stent outer diameter When crimped onto the mounting balloon, the coronary artery stent outer diameter will typically lie in a range from about 0.9 to about 1.2 mm, with an inner diameter in a range from about 0.6 to about 0.7 mm.
- the inner diameter of the stent when fully deployed to the expanded diameter at the target site will typically lie in a range from about 2.5 to about 6.0 mm.
- the final deployed diameter should be a size which will assure that the stent is retained in place, firmly engaged with the inner lining of the artery wall.
- a diameter of approximately 4.0 to 8.0 mm is appropriate.
- This stent size range is produced from tubing of one of the aforementioned core metal materials, typically 316L stainless steel, of 3.2 mm outside diameter and arranged and adapted to be expanded (opened) to a larger outside diameter by cutting a predetermined pattern of openings through the sidewall of the stent.
- core metal materials typically 316L stainless steel
- a principal size range of from 8.0 to 12.0 mm outside diameter, fully opened is desired.
- a range of diameter sizes from about 12.0 to 18.0 mm is adequate.
- a stent 10 fabricated according to the present invention is composed of three different primary or fundamental layers as shown in the greatly exaggerated fragmentary cross-sectional view of FIG. 2 , taken through the line 2 - 2 of FIG. 1 .
- the base layer 30 of the tubular member 12 of stent 10 is a biocompatible metal or an alloy of metals which has been or can be demonstrated to be suitable for implantation in the human body.
- Each of the other layers of the multi-layer structure of the stent is also biocompatible but that feature is not necessarily its primary characteristic, as well be understood from the description below. Focusing on the base layer or core material thickness 30 of the stent, materials such as 316L stainless steel, or nickel-titanium alloy known as nitinol which has a shape memory property, among others, are popular in medical implants and possess favorable characteristics of elasticity, mechanical strength and fatigue. The mechanical strength must be adequate to resist recoil of the vessel wall and to provide a scaffold that maintains an adequate lumen opening for the vessel being stented.
- Stent deployment may be achieved by active balloon inflation, or by passive spring opening attributable to pre-formed elasticity of the stent base material. These results are typically achievable with very thin-walled stents, in a range from 60 to 80 micrometers or microns (.mu.m) thick. However, the customary materials and material thicknesses are inadequate for sufficient visibility under fluoroscopic x-ray implantation or examination. In practice, this means that identifying the stent for deployment at the precise target site might be difficult, especially if the stent delivery system (e.g., a balloon catheter such as 23 in FIG.
- the stent delivery system e.g., a balloon catheter such as 23 in FIG.
- Z The atomic number (Z) of the base material.
- mm millimeter
- the stiffness of a stent increases directly with the thickness of the material of which it is composed. Stent stiffness increases the order of difficulty of implanting the stent, which is another reason for finding ways to reduce thickness without seriously affecting mechanical strength and radiopacity of the stent.
- the base material 30 such as 316L stainless steel is formed into an open-ended tubular structure of approximately 70 ⁇ m thickness, for example, and of selected appropriate length. Openings are cut (in the case of a tubular member with a solid wall, in contrast to a mesh or spring wound type) in a predetermined pattern through its sidewall, as by laser cutting, for example. This allows the stent diameter to be expanded (opened, e.g., during deployment) from a selected production diameter which will depend on the inner diameter of the vessel or duct in which the stent is to be inserted and advanced to a selected site of implantation. After openings are provide in the sidewall of the tubular member, it is subjected to customary cleaning and polishing steps.
- All exposed surfaces of the stent should be left at least slightly roughened, as by incomplete electro-polishing or by abrasion or by acid washing, or the like, to enhance adhesion of the next layer. Similar steps are followed if a shape memory or spring memory material is used, such as nitinol, although the stent itself in such a case might instead have a helical rather than a tubular configuration, which would eliminate the need for additional openings through a sidewall.
- this second, middle or intermediate layer 32 (again, these terms being used without limitation of the overall stent to only three layers or an absence of intervening layers) is preferably composed of a multiplicity of microspherical particles, or microspheres 33 , of suitable metal or alloy, ranging in size (diameter) from about 50 to 500 nanometers (nm) and applied to form a layer thickness in a range from about 4 to about 8 ⁇ m, preferably nominally about 5 ⁇ m, atop the exposed surfaces of the sidewall constituted by base layer 30 .
- the microspheres are built up on the surface of the tube in a manner such that the bottom or lowermost portion of the layer consists of microspheres adherent to the tube surface, and intervening portions up to the top or uppermost portion of this layer consist of microspheres connected or bonded (adherent) to one or more adjacent microspheres at points of tangency or near tangency (e.g., 35 ) therebetween.
- This configuration is such that voids or open spaces 37 are present throughout the layer, as interstices between adjacent microspheres.
- the intermediate layer may be characterized as being porous, and this is important for a purpose which will be discussed in detail presently.
- the platinum is preferably incorporated in an alloy with iridium, the latter in a percentage by overall weight in a range from about 2% to about 10%, preferably at or near the lower end of the range.
- the process by which the intermediate layer is applied preferably employs powder metallurgy.
- the surface tension and friction characteristic of the product to this point is improved over a stent having an ultra smooth surface.
- the particulate or powder metal is applied to the base layer surface and tightly bonded thereto, and built up to the desired layer thickness of high porosity by forming an interconnected multiplicity of the particles (microspheres), through application of heat.
- Suitable powder metallurgy processing for this material has been developed by Hittman Materials & Medical Components, Inc. of Columbia, Md.
- the interstices 37 constituting the spaces or voids between the spherical platinum-iridium particles 33 are sufficiently sized and plentiful as a result of the formation of layer 32 , to provide in overall effect a reservoir or repository for the infusion and retention of drugs which are beneficial or an aid to the use of the stent when implanted in a particular vessel or duct, such as in a coronary artery or other blood vessel. So the intermediate layer 32 provides not only the benefits of increased radiopacity of the stent, but also enables retention of drugs which may be released over time from the surface of the stent to enhance or inhibit certain functions.
- the outward facing surface of the stent and at least part of the edges of the openings adjacent thereto in the stent will ultimately be placed in contact and engagement with tissue of the inner lining of the artery wall.
- the inward facing surface forms the lumen of the stent, and portions of the edges of the openings 16 (in the multi-layer final structure) will be contacted by blood flowing through the artery (and thereby, through the lumen of the implanted stent).
- the voids or pores 37 in the outward facing surface and adjacent edge surfaces of intermediate layer 32 are advantageously used in total as a repository for drugs formulated to inhibit inflammation or proliferation of tissue from trauma of the stent engagement or related mechanism—drugs such as dexamethasone or taxol, respectively, or both.
- the spaces between particles in the inward facing surface and adjacent edge surface of intermediate layer 32 are, on the other hand, suitable for use as a repository of drugs to inhibit thrombus or platelet formation attributable to presence of the stent in the bloodstream—drugs such as hirudin or iloprost, respectively, or both.
- a third layer or coating 40 may be and preferably is formed on the exposed surface(s) of the intermediate highly porous layer 32 of interconnected spherical platinum-iridium particles 33 .
- This third or upper or outermost or superficial layer 40 is preferably composed of either iridium oxide (IROX) or titanium nitrate.
- IROX iridium oxide
- TiOX titanium nitrate.
- Each of these materials is in the nature of a ceramic, i.e., is ceramic-like, and although either one of them is preferred for this embodiment, each is exemplary of a biocompatible layer that serves a primary purpose of avoiding tissue irritation and thrombus formation.
- This outermost layer may be deposited as an inert coating over the surface(s) of the underlying intermediate layer 32 by any known method, preferably to a thickness in the range from about 10 to 500 nanometers (nm), preferably nominally 200 nm.
- Layer 40 need not and preferably does not fully coat all surfaces in the interstices of the porous intermediate layer 32 , but need merely cover the more exposed surfaces of particles 33 of that underlying layer, so that when the completed stent is ultimately deployed it is this outer coating 40 that principally if not solely contacts the inner lining of the vessel and the blood flowing through the lumen of the vessel. As shown in FIG. 2 , these are primarily the top surfaces of the uppermost spheres of intermediate layer 32 . Hence, a sputtering process is adequate for providing the coating, and more desirable than a process that would include immersion of the stent as fabricated to this point in a solution of iridium where more extensive surface coverage is desired, in the case of iridium oxide.
- porous underlayer 32 be left with its voids 37 intact, i.e., not filled or substantially blocked with iridium oxide or titanium nitrate, so that the reservoir or repository remains available after application of coating 40 , for infusion and retention of beneficial drugs.
- the intermediate porous layer 32 also serves the purpose of providing, a suitable underlayer, along with base layer 30 , to allow flexing of the stent over a vast number of cycles encountered in actual use without loss of the overlying iridium oxide or titanium nitrate coating from flaking, shedding or disintegration.
- the desired anti-inflammatory and/or anti-proliferation drugs are applied to enter the interstices of the porous medium constituting the outward facing surface and adjacent edges of openings of the stent.
- the desired anti-thrombotic and/or anti-platelet agents are applied to enter the interstices at the inward facing surface and adjacent edges of openings of the stent.
- the drug release response may be more carefully controlled by fabricating the intermediate layer 32 in a manner to position the larger spheres of the platinum-iridium particulate matter 33 directly adjacent and bonded to the base layer surface, and increasingly smaller-sized particles as the uppermost region of the layer is approached, as represented in the showing of FIG. 2 .
- This has the effect of increasing the size of the spaces 37 between particles at the bottom, and, thus, provides a larger reservoir or repository there, and of reducing the voids as the uppermost or outermost region is approached, whereby to reduce the spaces and reservoir volume in that region.
- the timed release of the beneficial drugs from the interstices of the porous layer 32 may be controlled by incorporating the drugs in a biodegradable carrier, preferably of a type described in the applicant's U.S. patent application Ser. No. 08/798,333.
- This carrier that contains the drugs or other applicable agents is represented at 43 , by way of example, in the fragmentary exaggerated cross-section of FIG. 2 .
- the time-controlled release in this case is attributable to the degradation or disintegration of the carrier itself, so that the drug or other agent remains captive within the carrier until it is dispensed or released, i.e., freed from its host, by progressive dissolution upon continuing diffusion of the carrier from the reservoir.
- gene transfer may be used to inhibit the smooth muscle cell growth that leads to neointima and restenosis.
- a viral vector is used to transfer the desired information into the genome of the target cells.
- Viruses capable of such gene transfer are, for example, adenovirus and herpervirus, or fractions of the virus. By viral transfer, which is believed to occur by virtue of absorption and diffusion, part of the genetic information of interest is provided to the target cell.
- Such information can relate to several mechanisms of smooth muscle cell proliferation, with the aim of inhibiting restenosis which, if unchecked, could result in at least partial and perhaps complete blockage of the vessel's lumen, despite the presence of the deployed stent at the site.
- One important technique involves blocking the proliferation stimulating factors such as cytoKines, n Fkappa b, platelet derived growth factors or other growth factors that originate from platelet deposition, thrombus formation, mechanical stress, or injury and inflammation.
- proliferation stimulating factors such as cytoKines, n Fkappa b, platelet derived growth factors or other growth factors that originate from platelet deposition, thrombus formation, mechanical stress, or injury and inflammation.
- the applicant herein is currently investigating whether selective inducement of apotosis—or programmed cell death—may be achieved via the fas-ligand, which would enable a programmed intervention against overshooting cellular proliferation in a narrowly controlled region of the tissue.
- the virus transfer is performed by incorporating the gene transfer agent—a viral vector or virus of the above-mentioned type that contains the viral genetic information desired to be transferred to the target cell(s)—into a biodegradable carrier, as at 43 of FIG. 2 , for release from the reservoir into which it has been infused and dispensed by the process of biodegradation.
- the release to effect the gene transfer may be accomplished by release from a solution in the reservoir which contains liposomes as the viral vector.
- the invention also contemplates the use of an intermediate high visibility layer which is completely solid, rather than porous, between the mechanical strength- and flexibility-providing layer which is the base material of the stent and the uppermost biocompatible layer.
- a solid intermediate layer is also preferably composed of a noble metal, and most preferably a platinum-iridium alloy in which the percentage of iridium is relatively small, e.g., about 2%, and which provides excellent surface characteristics to promote a strong bonding or adherence of the final coating of iridium oxide or titanium nitrate.
- the intermediate layer here may be applied by a conventional electroplating, for example, or other suitable process, instead of a powder metallurgy technique, for example, by which a porous thickness can be provided.
- the final coating has a sufficiently rough exposed surface to assure some attachment of a carrier incorporating the aforementioned drugs or other agents therein, albeit not to an extent offered by the reservoir or repository provided by the porous layer of the preferred embodiment.
- Layer thicknesses are substantially the same as those for the preferred embodiment which utilizes a porous intermediate layer.
- the basic process for fabricating a multi-layer stent of the type which has been described herein in conjunction with FIGS. 1 and 2 is illustrated in the flow chart of FIG. 3 .
- the basic metal tubular structure 12 with sidewall 30 is prepared or implemented in any conventional manner. The example of starting with a tube having a solid sidewall has already been described earlier in this detailed description.
- Metal particles 33 are next bonded to the surface of the sidewall or basic layer 30 as well as to themselves to form intermediate porous layer 32 , with sufficient voids between the particles therein to constitute a reservoir for retention of beneficial drugs, other agents, or virus vectors for gene transfer.
- An iridium oxide (or titanium nitrate) coating 40 is then applied to exposed surfaces of the porous layer 32 to provide a biocompatible surface for the overall basic stent.
- the drugs, agents and/or vectors to aid in overcoming undesired responses of the tissue and fluids of the body to intervention of the stent are infused into the interstices 37 together with a biodegradable carrier to fill or partially fill the reservoir from which they are dispensed after the stent is implanted in the body.
Abstract
Description
Claims (19)
Priority Applications (2)
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US13/303,601 US20120071966A1 (en) | 1998-04-11 | 2011-11-23 | Drug-releasing stent with ceramic-containing layer |
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